Qsymia

Sympathomimetic / Anti-epileptic Combinations

Qsymia is an extended-release combination of two existing medications: phentermine, used to suppress the appetite to aid in weight loss, and topiramate, used primarily to treat epilepsy and prevent migraine headaches but with a common side effect of weight loss. Qsymia has no generic alternative available. Another prescription option for weight loss, Belviq, is also now available.

What is Qsymia?


Commonly Used Brand Name(s): Qsymia

Therapeutic Classification: Appetite Suppressant, Centrally Acting

Chemical Classification: Phentermine

Phentermine and topiramate combination is used together with a reduced-calorie diet and proper exercise to help you lose weight. It is also used in overweight people who may also have diabetes, high blood pressure, high cholesterol, or heart disease.

This medicine is available only under a special restricted distribution program called Qsymia™ REMS program.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming (causing mental or physical dependence).

This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Take this medicine once a day in the morning, with or without food. Avoid taking this medicine in the evening to prevent trouble sleeping.

Swallow the extended-release capsule whole. Do not crush, break, or chew it.

Carefully follow your doctor's instructions for a reduced-calorie diet plan and regular exercise. Talk with your doctor before starting any exercise program.

Your doctor should tell you to stop taking this medicine if you do not lose a certain amount of weight within the first 12 weeks of treatment.

It is important that you drink extra water every day while you take this medicine to help prevent kidney stones.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (extended-release capsules):
    • For weight loss:
      • Adults—At first, one tablet of 3.75 milligrams (mg) of phentermine and 23 mg of topiramate once a day for 14 days. After 14 days, your doctor may increase your dose to 7.5 mg of phentermine and 46 mg of topiramate once a day. Then, your doctor may increase your dose as needed up to 15 mg of phentermine and 92 mg of topiramate.
      • Children—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of phentermine and topiramate combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of phentermine and topiramate combination in the elderly. However, elderly patients are more likely to have kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving phentermine and topiramate combination.

Pregnancy

Pregnancy CategoryExplanation
All TrimestersXStudies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Brofaromine
  • Clorgyline
  • Furazolidone
  • Iproniazid
  • Isocarboxazid
  • Lazabemide
  • Linezolid
  • Moclobemide
  • Nialamide
  • Pargyline
  • Phenelzine
  • Procarbazine
  • Rasagiline
  • Selegiline
  • Sibutramine
  • Toloxatone
  • Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.

  • Ethanol

Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Allergy to similar medicines (e.g., adrenaline, amphetamine, dopamine, dobutamine, ephedrine, or lisdexamfetamine) or
  • Glaucoma or
  • Hyperthyroidism (overactive thyroid)—Should not be used in patients with these conditions.
  • Bone problems (e.g., osteoporosis) or
  • Depression, history of or
  • Drug abuse or dependence, history of or
  • Eye or vision problems or
  • Hypokalemia (low potassium in the blood) or
  • Kidney stones, history of or
  • Mental illness, history of or
  • Metabolic acidosis (too much acid in the blood), history of or
  • Seizures or epilepsy, history of—Use with caution. May make these conditions worse.
  • Diarrhea or
  • Ketogenic diet (high-fat, low-protein, low-carbohydrate diet) or
  • Kidney problems or
  • Lung disease or other breathing problems or
  • Status epilepticus (e.g., a state of epilepsy where you have many seizures in a row and do not gain consciousness) or
  • Surgery—These problems may make a condition called metabolic acidosis occur or make it worse.
  • Heart or blood vessel disease, unstable—Use is not recommended in patients with these conditions.
  • Kidney disease, moderate or severe or
  • Liver disease, moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

It is very important that your doctor check your progress at regular visits, to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

You must have a negative pregnancy test before you will be allowed to take this medicine. You will also be required to have a pregnancy test every month during your treatment. If you miss a period while you are using this medicine, tell your doctor right away.

Do not use this medicine if you have used an MAO inhibitor (MAOI) such as Eldepryl®, Marplan®, Nardil®, or Parnate® within the past 14 days. Using these medicines together may cause serious unwanted effects.

This medicine may be habit-forming. If you think this medicine is not working properly after you have taken it for a few weeks, do not increase the dose. Instead, check with your doctor.

This medicine may increase your heart rate. Check with your doctor right away if you have a racing heartbeat while at rest after taking this medicine.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these side effects, tell your doctor right away.

Check with your doctor immediately if you have a decrease in vision, blurred vision, or pain around the eyes during and after treatment with this medicine. Your doctor may want you to have your eyes checked by an eye doctor.

This medicine may cause some people to become dizzy, drowsy, or have trouble in thinking or speaking. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert, well-coordinated, or able to think or see well.

This medicine may cause nausea, muscle tremors, fast breathing, problems eating, fast heartbeat, restlessness, and abdominal or stomach pain. Tell your doctor right away if you have any of these symptoms. This may be a sign that you may be having a metabolic acidosis (too much acid in the blood).

For diabetic patients: This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

For patients with high blood pressure: This medicine may increase risk of lowering your blood pressure. If you feel dizzy, faint, or lightheaded after taking this medicine, check with your doctor.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds, prescription pain medicines, or sleep medicines. Check with your doctor before taking any of the above while you are using this medicine.

Do not suddenly stop taking this medicine without first checking with your doctor. Stopping the medicine suddenly may cause your seizures to return or to occur more often. Your doctor may want you to gradually reduce the amount you are using before stopping completely.

Check with your doctor right away if you have sudden back pain, abdominal or stomach pain, pain while urinating, or bloody or dark urine. These may be symptoms of kidney stones.

This medicine may make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are taking this medicine. Overheating may result in heat stroke. Also, hot baths or saunas may make you dizzy or faint while you are taking this medicine.

This medicine may cause your body temperature to go down especially when taking valproic acid, which is a medicine to control seizures. You may have tiredness, weakness, confusion, and abnormal heartbeat and breathing. Tell your doctor right away if you feel any of these side effects.

Birth control pills (containing estrogen) may not work properly if you take them while you are taking this medicine. Unplanned pregnancies may occur. You should use a different or additional means of birth control while you are using this medicine. If you have any questions about this, check with your doctor or pharmacist.

Check with your doctor right away if you are having unusual drowsiness, dullness, tiredness, weakness, or feelings of sluggishness, mental depression or anxiety, nightmares or unusually vivid dreams, or vomiting. These may be symptoms of a serious condition called hyperammonemic encephalopathy.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements (including any weight loss products).

They need to know if you have any of these conditions:

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not crush or chew. This medicine is usually taken with or without food once per day in the morning. Avoid taking this medicine in the evening. It may interfere with sleep. Take your doses at regular intervals. Do not take your medicine more often than directed.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.

Store at room temperature between 15 and 25 degrees C (59 and 77 degrees F). Throw away any unused medicine after the expiration date.

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